3 Ways Digital Pills Can Change the Future of Medicine
A new digital pill that tracks whether patients are taking their medication has been approved by the Food and Drug Administration (FDA).
Abilify MyCite is designed with a sensor that is safe to swallow. The pill works in tandem with a patch worn by the patients.
Additionally, the product comes with a smartphone app that can record patient behavior data. While this may sound mundane, it is anything but.
The Abilify news should conjure up memories of Amazon’s business model circa 1997.
The groundbreaking technology is not just the integrated sensor technology. Instead, the FDA approval is the big story here. Proteus Digital Health is the Redwood City, California-based manufacturer that makes the sensors matched with Otsuka’s Abilify product (Otsuka a the Japanese pharmaceutical company).
People who suffer from mental disorders such as schizophrenia, bipolar and depression understand how important it is to stay on top of their medication schedules to keep their health under control. Abilify MyCite will make even the most forgetful person more responsible with their medication.
The digital health industry includes many Silicon Valley based startups that perfecting medical breakthroughs, mobile health, and virtual care. While Proteus just notched a major victory, its digital health competitors can learn lessons from Proteus’ regulatory strategy.
While the initial 510(k) by Proteus and Otsuka was rejected by the FDA in April 2016, they did secure approval a year later. In doing so, Proteus established a novel technology known as an ‘ingestible event marker’ (IEM). This IEM technology could be used in various applications, however, with Abilify MyCite it is narrowly focused.
Who Can Use Abilify MyCite?
Patients with severe mental illnesses will work in collaboration with their healthcare professionals to determine if Abilify MyCite is right for them. Abilify is not approved for the treatment of dementia-related psychosis as elderly patients on antipsychotics have an increased risk of death.
Conditions commonly treated with Abilify that are eligible for the digital pill include:
- Schizophrenia
- Bipolar Disorder
- Severe depression
Abilify is safe for people over the age of 13 who suffer from schizophrenia and children over 10 who are diagnosed with bipolar I disorder. Abilify is also sometimes used for children that have Tourette’s syndrome or are on the autism spectrum.
How Does Abilify MyCite Work?
The ingestible sensor inside of the digital pill is comparable to a grain of sand and made from magnesium, copper, and silicon. The genius to the Abilify MyCite is in the underlying transmitter and patch, which are Proteus’ technology.
keep in mind that the FDA’s press release in November 2017 made this clear distinction between drug and device:
“Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012.
The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. The sensor technology and patch are made by Proteus Digital Health.”
Medical device manufacturers could mimic Proteus’ strategy by analyzing their regulatory filings. Let’s take a look at Proteus Digital Health’s 2012 De Novo application.
Medication adherence is just the first phase of a larger platform play. Digital pills can have multiple indications, such as, time-released drugs or drugs that are activated in specific organs.
Digital health competitors could develop their own ‘Ingestion Event Marker’, ‘Patch’, and proprietary software in order to not get left behind. If not, competitors risk missing out on these three core Abilify MyCite functions:
- When the pill encounters stomach acid, an electrical signal is produced that transmits to a patch worn by the patient on their left side rib cage.
- The digital pill signal takes several minutes to transmit. However, the data is stored on a smartphone app that is linked to the patch. The patch is good for 7 days and the sensor will pass through the body naturally, without notice.
- Patients can permit their doctor (and up to four others) to access their digital pill data. The patient can revoke access at any time.
Proteus is well-positioned in the digital health space because of their core technology. Not only can it be used with Abilify’s drug, but rather hundreds of other pharmaceutical pills.
Future of Digital Medicine
Abilify MyCite and the concept of digital pills revolutionizes digital medicine in 3 key ways.
- Medication Adherence — The IMS Institutes estimates that the US healthcare sector spends over $200 billion on improper and unnecessary medication usage. Patients also become more engaged in their care and have vastly improved health outcomes. Dr. Marie Brown from Rush University Medical Center claims that half of all mental health patients do not take their medications as prescribed. With 15% of adults in the U.S. taking more than five prescriptions a day, medication adherence is understandably challenging.
- Future Pill Roadmap — This first FDA approved digital pill is just the beginning. With Otsuka (a Japanese pharmaceutical company) and Proteus Digital Health, this pill will unlock insight into patient health. Data will suddenly become available allowing doctors and statisticians to learn more about underlying issues. As more data is generated, more manufacturers will enter the market with novel form factors.
- Treatment Optimization — When physicians have objective data on medication adherence, then they are able to more properly diagnose, and treat their patients. This is especially valuable for the future of mental health. As patients log their moods, sleep habits, and other information into the smartphone app, then patterns will emerge. Patterns that can be analyzed to optimize treatments for mental health and other future indications.
Seldom are game-changing technologies found in the drug space. If Proteus plays their cards right, then they will have a successful platform technology. Their digital pill can be combined with a range of pharmaceuticals in the future. All at the tap of a cellphone app. The future of drug delivery may never be the same again.
